BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    COUNTER-ROTATION SYSTEM

    K Number: K821256 · Decision Jun 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    54

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    Basic Information

    Device Name
    COUNTER-ROTATION SYSTEM
    K Number
    K821256
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3675
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    The Langer Group
    Date Received
    April 30, 1982
    Decision Date
    June 23, 1982
    Product Code
    ITN
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITN Splint, Denis Brown

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    Other Clearances by The Langer Group

    K Number Device Name
    K821255 ELECTRODYNOGRAM SYSTEM